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• Regulatory feedback recent from April 2026 EU EMA and Australian TGA meetings • Remaining Q2-2026 regulatory meetings include two U.S. FDA meetings and one UK MHRA meeting, in addition to follow-up meetings with EU EMA and Australian TGA

• Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia • Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint • TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3 • FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC) • Market access process initiated with UK NICE and EU JCA

While life sciences employment was down 0.3% nationally in 2024, it rose 1.9% in Washington, according to a new Life Science Washington report. The association’s CEO discusses the latest findings and how the state’s job market looks this year.